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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000011789
Date of registration: 20/09/2013
Prospective Registration: No
Primary sponsor: National Health Organization Nagoya Medical Center
Public title: Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis
Scientific title:
Date of first enrolment: 2010/09/21
Target sample size: 20
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013741
Study type:  Interventional,observational
Study design:  Single arm Non-randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Daihei Kida   
Address:  4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Aichi, JAPAN Japan
Telephone: 052-951-1111
Email: kidad@nnh.hosp.go.jp
Affiliation:  National Health Organization Nagoya Medical Center Orthopedic Surgery and Rheumatology
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients with rheumatoid arthritis (meeting the ACR criteria in 2010)
2. Patients who had a response to intravenous treatment with ABT at a dose of 2 vials within 3 months before dose increase and had less than 4% decrease in DAS28-ESR over 4 weeks before dose increase
3. Patients who gave oral presentation of informed consent

Exclusion criteria: None

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
Intervention(s)
Administration of increased dose of abatacept to patients with rheumatoid arthritis previously treated with abatacept.
Primary Outcome(s)
The effect of dose increase of abatacept:
1. Number of painful joints
2. Number of swollen joints
3. VAS (patient's global assessment)
4. VAS (physician's global assessment)
5. Erythrocyte sedimentation rate
6. CRP
7. DAS28-ESR
8. DAS28-CRP
9. mHAQ
10. MMP-3
Secondary Outcome(s)
1. DAS28-ESR and DAS28-CRP according to the dose per kg body weight
2. EULAR Response
3. ACR20
4. Adverse events
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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